BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 18183473 · Received November 21, 2023

    Report

    Report Number
    2247858-2023-00293
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    August 23, 2023
    Report Date
    November 21, 2023
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVOLVED WITH THREE DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR 2247858-2023-00293, DEVICE 2 IS BEING REPORTED UNDER MDR 2247858-2023-00294 AND DEVICE 3 IS BEING REPORTED UNDER MDR 2247858-2023-00295. BOLTON MEDICAL, INC. (D/B/A TERUMO AORTIC), HEREIN KNOWN AS THE "COMPANY", IS SUBMITTING THIS REPORT PURSUANT TO 21 CFR PART 803, HAS MADE REASONABLE EFFORTS TO OBTAIN COMPLETE INFORMATION, AND HAS PROVIDED AS MUCH AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT IS BASED ON INFORMATION OBTAINED BY THE COMPANY, WHICH MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE REGULATIONS. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY ANYONE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE CERTAIN REGULATIONS, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    "BILATERAL ILIAC ARTERY GRAFT THROMBUS DISCOVERED DURING OFFICE VISIT ON (B)(6) 2023. PATIENT DEVELOPED THROMBUS ON AND ADJACENT TO STENT GRAFT WITH NO EVIDENCE OF DISTAL EMBOLUS. PATIENT WAS SUBSEQUENTLY PLACED ON ELIQUIS (5MG, 2X PER DAY), ASPIRIN (81MG PER DAY), AND ATORVASTATIN (40MG PER DAY) WITHOUT COMPLICATIONS. (B)(6) RETURNED FOR 1 YEAR FOLLOW-UP VISIT ON (B)(6) 2023 IN WHICH THE CTA REPORT FOUND "STABLE ANEURYSMAL SAX SIZE WITH PERSISTENT TYPE II ENDOLEAK. NEW NON-OCCLUSIVE THROMBUS IN THE PROXIMAL ASPECT OF THE LEFT COMMON ILIAC LIMB OF THE STENT-GRAFT. PER INVESTIGATOR, PATIENT STILL HAS THROMBUS ON HIS GRAFT AND APPARENTLY IT NOW IS INVOLVING A SLIGHTLY DIFFERENT AREA THAT IT WAS BEFORE. IT IS UNCLEAR TO ME WHY THIS IS OCCURRING, AS THIS IS SOMETHING WE DO NOT GENERALLY SEE UNLESS THERE IS A LARGE DIAMETER CHANGE BETWEEN THE GRAFT COMPONENT, IT IS NOT IN THIS CASE." PATIENT OUTCOME - "PER INVESTIGATOR, PLAN IS TO RETURN TO CLINIC IN 12 MONTHS WITH AN ULTRASOUND OF THE AORTA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165422 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2104230172

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other